Irregular Rhythm Notification Feature (IRNF)

FDA 510(k) K231173 · Apple, Inc.

Substantially Equivalent

510(k) numberK231173

Submission

Device name
Irregular Rhythm Notification Feature (IRNF)
Applicant
Apple, Inc.
Cupertino, CA, US
Received
April 25, 2023
Decision date
July 21, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QDB – Photoplethysmograph Analysis Software For Over-The-Counter Use
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2790
Specialty
Cardiovascular

A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a diagnosis.

Other 510(k)s with product code QDB

510(k)DeviceApplicantDecision
K213971Atrial Fibrillation History FeatureQDB · Traditional Apple, Inc.06/03/2022SE
K212372Fitbit Irregular Rhythm NotificationsQDB · Traditional Fitbit, Inc.04/08/2022SE
K212516IRNF AppQDB · Traditional Apple, Inc.10/22/2021SE

More from Apple, Inc.

510(k)DeviceDecision
K253582Medical Imaging Calibration Feature (MICF)SHN · Traditional 04/01/2026SE
K250507Hypertension Notification Feature (HTNF)SFR · Traditional 09/11/2025SE
K250143Digital Prism Correction Feature (DPCF)SCW · Traditional 06/23/2025SE
K242058Digital Prism Correction Feature (DPCF)SCW · Traditional 10/21/2024SE
K240929Sleep Apnea Notification Feature (SANF)QZW · Traditional 09/13/2024SE
K213971Atrial Fibrillation History FeatureQDB · Traditional 06/03/2022SE
K212516IRNF AppQDB · Traditional 10/22/2021SE
K201525ECG AppQDA · Traditional 10/08/2020SE

Questions and answers

When was Irregular Rhythm Notification Feature (IRNF) cleared by the FDA?

Irregular Rhythm Notification Feature (IRNF) (K231173) received a 510(k) decision of Substantially Equivalent on July 21, 2023, 87 days after the submission was received.

What is the product code of K231173?

The FDA product code is QDB – Photoplethysmograph Analysis Software For Over-The-Counter Use, a Class II (moderate risk) device regulated under 21 CFR 870.2790.